the use of outcome measures to evaluate the efficacy and tolerability of antipsychotic medication: a...
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Journal of Psychiatric and Mental Health Nursing, 2001, 8, 191–196
© 2001 Blackwell Science Ltd 191
The use of outcome measures to evaluate the efficacy andtolerability of antipsychotic medication: a comparison of Thorngraduate and CPN practiceR. GRAY1 rn bsc(hons), T. WYKES2 phd , A.-M. PARR3, E. HAILS4 rn msc enb a48 pgce &
K. GOURNAY5 cbe mphil phd cpsychol afbpss frcn rn1MRC Fellow, Health Services Research Department, Institute of Psychiatry, 2Professor of Rehabilitation andClinical Psychology, Department of Psychology, 3Research Worker, 4Thorn-Tutor, and 5Professor of PsychiatricNursing, Health Services Research Department, Institute of Psychiatry, De Crespigny Park, London, UK
GRAY R., WYKES T., PARR A.-M., HAILS E. & GOURNAY K. (2001) Journal of Psychiatric and Mental Health Nursing 8, 191–196
The use of outcome measures to evaluate the efficacy and tolerability of antipsychotic medication: a comparison of Thorn graduate and CPN practice
Assessing the tolerability and efficacy of treatment with antipsychotic medication is a vital
part of mental health care. Research has suggested that many side-effects go undetected by
clinicians and there is a need to use standardized assessment tools to ensure that treatments
are comprehensively evaluated. The training of Community Psychiatric Nurses (CPNs),
who provide much of patients’ care, should focus on enhancing skills in using such assess-
ments. This study aimed to examine differences in the use of standardized assessments of
antipsychotic side-effects and psychopathology by CPNs and Thorn graduates who had
received additional training in delivering psychosocial interventions. A questionnaire was
sent to 240 Thorn graduates and CPNs practising in England, with an overall adjusted
response rate of 54%. Thorn graduates reported using significantly more standardized
assessments of side-effects and psychopathology than CPNs. A trend in both groups
towards the use of measures that relied on patient self-report of side-effects was observed.
This study identified important deficiencies in current CPN practice. A programme of
targeted training may be a more realistic and efficient method of enhancing medication
management practices in large numbers of CPNs compared to the more expensive and time-
consuming Thorn programme.
Keywords: antipsychotic, CPN, survey, Thorn, training
Accepted for publication: 12 October 2000
Correspondence:
R. Gray
Health Services Research
Department
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
UK
Background
Antipsychotic agents have been a mainstay in the manage-
ment of schizophrenia since they were introduced in the
1950s (Moore 1999). Whilst effective in ameliorating
many of the distressing symptoms of schizophrenia, they
are associated with a range of problematic side-effects
including extrapyramidal symptoms (EPS). Up to 75% of
patients treated with conventional antipsychotics experi-
ence EPS (Casey 1996), which are not only distressing
but are a major cause of noncompliance (van Putten
1974).
Despite the distress and increased risk of noncompliance
associated with the side-effects of antipsychotic medica-
tion, a number of studies have found that many side-effects
go undetected by clinicians. In an examination of 55 CPNs’
practice in assessing side-effects, Bennett et al. (1995)
reported that they asked patients about only three or four
R. Gray et al.
192 © 2001 Blackwell Science Ltd, Journal of Psychiatric and Mental Health Nursing 8, 191–196
possible side-effects from antipsychotic medication. Similar
findings were reported by Gray (1998), who found that
fewer than 50% of the 27 CPNs surveyed routinely
assessed patients for EPS. However, even if CPNs do
perform an assessment of side-effects, a substantial
proportion of symptoms may still remain undetected.
Wieden et al. 1987) compared the assessment of EPS by
clinicians in routine practice with those of researchers
trained to use standardized assessments. The results
suggested that clinicians in routine practice only detected
26% of the patients with akathisia and 59% of the
patients with Parkinsonism that had been identified by the
researchers.
Perhaps these findings may be explained by clinicians
underestimating the importance of antipsychotic side-
effects. Evidence to support this conclusion comes from
Hoge et al. (1990), who prospectively interviewed 1434
patients admitted to four inpatient units during a six-
month period about refusal of treatment with anti-
psychotic medication. Thirty-five per cent of noncompliant
patients cited side-effects as the main reason for stopping
medication, whilst only 7% of clinicians gave the same
reason.
Evaluating the efficacy and tolerability of treatments
is clearly a critical component of good mental health
care. The use of valid and reliable measures, such as the
Liverpool University Neuroleptic Side-Effect Rating Scale
(LUNSERS; Day et al. 1995) has been recognized as the
most robust way of reviewing the impact of pharmaco-
logical interventions. Indeed, such practice is embedded
within the new National Service Framework for mental
health (DoH 1999).
Since 1992, a major post-registration training initiative
for CPNs has been the Thorn course, developed jointly by
Manchester University and the Institute of Psychiatry in
London (Lancashire et al. 1997). This skills-based pro-
gramme aims to train mental health professionals to use
evidenced-based psychosocial interventions (problem-
orientated case management, cognitive behavioural
interventions for psychosis and schizophrenia family
work), including the use of standardized assessments of
psychopathology and antipsychotic side-effects. Trainees
have approximately 250 hours’ contact with trainers of
which around 12 hours is devoted specifically to medica-
tion management (Lancashire et al. 1997, Gournay &
Birley 1998).
This study aimed to provide evidence of Thorn
graduates’ and CPNs’ reported use of recognized out-
come measures to evaluate the efficacy and tolerability of
antipsychotic medication. Differences in Thorn graduates’
and CPNs’ perceptions of their role in medication man-
agement, knowledge about psychopharmacology and
future training requirements were also explored.
Method
Power calculation
A power calculation was performed to determine the
number of CPNs which would need to be surveyed to
detect the proportion who utilize standardized anti-
psychotic side-effect scales in clinical practice. Assuming a
population of 6700 CPNs (Brooker & White 1997) and
that an estimated 40% use at least one recognized assess-
ment tool (Gray 1998), a sample of 91 CPNs would be
necessary to achieve a confidence level of 95%. Assuming
a non-response rate of 40–60%, a sample size of 240
was estimated to meet the requirements of the power
calculation.
Sample selection
As no comprehensive national database of CPNs working
in the UK exists, the sample for this study was generated
using two different methods. Thorn graduates were iden-
tified by contacting the course leaders in both London and
Manchester requesting a list of the names and addresses of
all trainees who had successfully completed training. CPNs
were identified by inviting six geographically diverse Trusts
throughout England where Thorn training was not cur-
rently provided to participate. Those Trusts who agreed to
take part provided a list of CPNs currently in clinical prac-
tice who met the following inclusion criteria: they were a
registered nurse, currently engaged in clinical practice, with
a caseload of patients living in a community setting. From
these lists of 227 CPNs and 246 Thorn graduates the
sample was selected. Each nurse was allocated a number,
which was then sorted into a random order. The first 120
nurses in each group (total 240) were then selected and sent
a brief questionnaire, with a covering explanatory letter
and consent form, to complete and return.
Questionnaire
The 38-item questionnaire was developed based on previ-
ous research (Bennett et al. 1995) and consultation with a
group of experienced clinicians and academics (a Professor
of Psychiatric Nursing, a Consultant Clinical Psychologist,
a Consultant Psychiatrist, a Clinical Nurse Specialist and
a Thorn Tutor). The questionnaire, which was intended to
be brief and easy to complete, was designed to elicit infor-
mation about clinician demographics, caseload composi-
Use of outcome measures
© 2001 Blackwell Science Ltd, Journal of Psychiatric and Mental Health Nursing 8, 191–196 193
tion, use of valid and reliable assessment tools, knowledge
about psychopharmacology and training requirements.
The majority of questions required tick-box responses.
Information about the composition of caseloads was
obtained by asking CPNs to calculate the proportion of
their patients who were suffering from different disorders.
Respondents were also asked to list all the assessment tools
they regularly used in their clinical practice. Knowledge
about psychopharmacology was determined by asking
respondents to give an agree, disagree, or unsure response
to nine statements about psychopharmacology. A score of
2 was given for a correct answer, 1 for unsure, and 0 for
an incorrect answer, producing a total score ranging from
0 to 18. The expert group paid considerable attention to
devising a list of questions that a CPN should ideally be
able to answer given appropriate training. This method of
examining knowledge has been used before and has been
shown to be, potentially, reliable and easy to administer
(Gamble et al. 1994). The complete questionnaire is avail-
able from the authors on request.
The questionnaire was piloted on a cohort of 58 CPNs
(Gray 1998) and the analysis of these responses allowed
the questionnaire to be further refined, by removing un-
necessary items and rephrasing certain questions.
Questionnaires were sent out in November 1998,
together with a covering letter explaining the nature and
purpose of the study. A reminder letter was sent eight
weeks later if CPNs had not responded. Respondents
were asked to sign and return a consent form with the
questionnaire.
Statistics
Data were analysed using SPSS for windows, version 8.0.
To identify between group differences, independent sample
t-tests were used. The chi-square statistic (c2) was utilized
to test for association. All tests were two-tailed.
Results
Response rates and non-response bias
Of the 240 questionnaires that were sent out 144 (60%)
were returned. Of these, 30 were excluded because respon-
dents either had never worked as CPNs or were not cur-
rently working as CPNs, giving an adjusted response rate
of 54%. All returned questionnaires contained completed
consent forms. There was no significant difference in the
adjusted response rate from Thorn graduates (53%) and
CPNs (54%). A response rate of 54% may represent a
significant non-response bias. However, given that 30
respondents (mainly Thorn graduates) were not currently
working as CPNs or had never worked as CPNs, it is
likely that the same was true of a proportion of the
non-responders, which may reduce the bias.
Demographics
The demographic profile of the two groups did not differ
significantly. Of the 114 respondents, 49% were male,
90% classified themselves as white and had a mean age of
40 years (range 24–57, SD 7.5). The majority of CPNs
(69%) and Thorn graduates (64%) were employed at
grade ‘G’. Both CPNs and Thorn graduates had, on
average, 15 years post-registration experience, and there
was no significant difference in time spent working in the
community (CPNs 8 years; Thorn graduates 7 years). All
Thorn graduates and 69% of CPNs were qualified to at
least undergraduate diploma level.
The role of the CPN
Although Thorn graduates had significantly smaller case-
loads than CPNs (24 vs. 37; t = 4.53, d.f. = 110, P <
0.0009), there was no significant difference in the propor-
tion of patients with serious and enduring mental disorders
(schizophrenia, dementia, bi-polar illness, severe eating
disorder; Goldberg & Gournay 1997).
Respondents were asked to indicate whether a range of
commonly used therapeutic approaches were an impor-
tant part of their role as a CPN. The list included the
following medication management interventions: assessing
patient’s mental state (to evaluate pharmacological inter-
ventions), monitoring antipsychotic side-effects and
enhancing compliance. The results are presented in Table
1. No significant difference between the two groups was
observed, with both indicating that medication manage-
ment interventions are an important part of their role.
Assessing side-effects
There was no significant difference in the frequency with
which Thorn graduates and CPNs reported asking patients
about antipsychotic side-effects, with 80% of both groups
assessing side-effects at least once a month. However, side-
effect assessment tools were used by significantly more
Thorn graduates than CPNs (62% vs. 25%; c2 = 8.61, d.f.
= 1, P = 0.003). The most widely used measure of anti-
psychotic side-effects, in both groups, was the LUNSERS
(Liverpool University Neuroleptic Side-Effect Rating Scale;
Day et al. 1995), although this was used by significantly
more Thorn graduates than CPNs (56% vs. 25%; c2 =
R. Gray et al.
194 © 2001 Blackwell Science Ltd, Journal of Psychiatric and Mental Health Nursing 8, 191–196
11.38, d.f. = 1, P = 0.001). The Simpson Angus Extrapyra-
midal Side-Effect Rating Scale (Simpson & Angus 1970)
was also used by a small number of Thorn graduates,
which was significantly greater than the number of CPNs
using it (10% vs. 0%; c2 = 6.69, d.f. = 1, P = 0.01). Fewer
than 5% of both Thorn graduates and CPNs reported
using the AIMS (Abnormal Involuntary Movement Scale;
Guy 1976). The use of self-developed measures to assess
side-effects was also reported by significantly more Thorn
graduates (24% vs. 5%, c2 = 9.16, d.f. = 1, P = 0.002). No
other measures were reported as being used.
Assessment of psychopathology
The only recognized assessment of psychopathology used
by respondents in either group was the KGV (Krawiecka
et al. 1977). Thorn graduates were significantly more likely
to report using it in clinical practice than CPNs (40% v
5%, c2 = 21.73, d.f. = 1, P < 0.0009).
Knowledge about psychopharmacology
No significant difference in mean total scores on the
knowledge questionnaire were observed between Thorn
graduates (mean 14.64; range 8–18; s.d. 1.92) and CPNs
(mean 13.58; range 9–17; s.d. 1.85). Scores were at the
upper end of the 0–18 range and may indicate that res-
pondents generally had good levels of knowledge about
psychopharmacology. There were consistent deficits in
both groups’ understanding about novel antipsychotic
treatments and the causes and management of EPS.
Need for training
Respondents were asked to rate their individual training
needs on a 1 (low priority) to 9 (high priority) scale and
results are shown in Table 2. Generally, respondents
reported a need for training in all proposed areas with the
exception of anxiety management and relaxation. Both
groups rated medication management interventions, risk
assessment and suicide prevention as high priorities for
training. Thorn graduates placed a significantly greater
emphasis on the need for training in compliance and
cognitive behavioural interventions.
Discussion
The aim of this study was to establish whether CPNs and
Thorn graduates differ in their reported use of recognized
outcome measures to evaluate pharmacological inter-
ventions. Results demonstrate that Thorn graduates report
using more standardized side-effect and mental state
assessment tools than do CPNs but were no more knowl-
edgeable about psychopharmacology. The sample meets
the requirements of the power calculation and the profile
of respondents is comparable to the national survey of
CPN services (Brooker & White 1997), suggesting that
results may be generalized.
The majority of CPNs indicated that evaluating the
effects of antipsychotic medication was part of their role.
However, despite evidence from Wieden et al. (1987) that
clinicians fail to detect a substantial proportion of side-
effects if they do not use assessment tools, only a minority
Table 1The role of the CPN
percentage of respondentswho agreed that intervention was an important part of their role
Intervention CPN Thorn
Assessing mental state 96.9 100.0Risk assessment 90.6 95.8Monitoring side-effects 87.3 95.8Suicide prevention 87.3 91.7Crisis intervention 71.9 85.7Case management 65.6 77.6Enhancing compliance 61.9 75.5Mental health promotion 58.7 58.0Giving depots 50.0 60.4Anxiety management 40.6 44.7Cognitive behaviour therapy* 31.3 65.3Counselling 30.6 25.0Family work† 27.0 61.2Relaxation therapy 18.0 20.8
* = 13.98, d.f. = 2, P = 0.001.† = 15.46, d.f. = 2, P < 0.0009.
Table 2Priorities for training (1 low priority – 9 high priority)
Priority for training score
Training area CPN Thorn
Suicide prevention 8.40 8.38Risk assessment 8.35 8.47Assessing mental state 8.28 8.44Monitoring side-effects 7.87 8.36Crisis intervention 7.49 7.88Care programme approach 7.37 7.42Case management 7.29 7.77Mental health promotion 7.23 7.55Enhancing compliance* 6.77 7.58Cognitive behaviour therapy† 6.57 7.78Family work‡ 6.48 8.02Giving depots 6.24 6.61Counselling§ 6.07 5.14Relaxation therapy 5.18 5.63Anxiety management 5.60 6.06
*t = 107, P = 0.010.†t = 108, P < 0.0009.‡t = 109, P < 0.0009.§t = 2.3, P = 0.022.
Use of outcome measures
© 2001 Blackwell Science Ltd, Journal of Psychiatric and Mental Health Nursing 8, 191–196 195
of CPNs reported that they made use of such procedures
in their practice. This suggests that respondents are failing
to evaluate how well their patients are tolerating antipsy-
chotic medication, a finding that is consistent with Bennett
et al. (1995) and Gray (1998). That only a small number
of CPNs reported using measures of psychopathology also
appears to indicate that a regular review of the efficacy of
medication is not being performed. The failure of CPNs to
evaluate both the tolerability and efficacy of medication is
incongruent with the standards set out in the National
Service Framework (DoH 1999) and may expose a lack of
training in the use of assessment tools. The high priority
respondents, particularly Thorn graduates, placed on
medication management training may indicate an aware-
ness of the deficits in their current practice.
Respondents in both groups used primarily self-report
scales such as the LUNSERS to detect side-effects. Whilst
self-report is useful, it relies on patients being aware of
side-effects. This is not always the case; for example
patients may not always be aware of tremor, stiffness or
abnormal body movements. This highlights the importance
of other types of assessment tools that use observation and
physical examination as a basis for rating.
Although the results from the knowledge component
of the questionnaire should be treated with caution, no
significant between-group differences in knowledge about
psychopharmacology were found. However, important
deficits in knowledge were observed among both groups,
particularly about atypical antipsychotics. This may reflect
the comparatively small amount of time within the Thorn
programme devoted specifically to psychopharmacology. It
is possible that a poor understanding about psychophar-
macology may limit the strategies used by both groups to
help patients manage antipsychotic side-effects. Perhaps
there is a need to increase the amount of time dedicated to
psychopharmacology within Thorn training.
Results from this study suggest that Thorn graduates
make more use of outcome measures to evaluate the
efficacy and tolerability of antipsychotic medication and
suggest that training has been beneficial in this area.
However, only about half stated that they were currently
using such measures in their clinical practice. This finding
suggests that factors other than training, such as caseload
size and lack of clinical supervision, may also have an
important influence on practice.
Conclusion
The evaluation of both the efficacy and tolerability of
antipsychotic treatment is critical if side-effects are to be
minimized and compliance enhanced. The results of this
study confirm previous research and suggest that only a
minority of CPNs use standardized measures to evaluate
pharmacological interventions. Although Thorn graduates
report using more outcome measures in routine clinical
practice, they tend to rely on self-report checklists to iden-
tify side-effects. Around a third indicated that they no
longer used the measures they had been trained in; the
reasons for this are unclear. The study also highlights
important deficiencies in both groups’ understanding of
psychopharmacology. As a model for increasing the use of
outcome measures to evaluate antipsychotic medication,
Thorn training may be useful. However, many patients
continue to experience unwanted side-effects that could
easily be treated if CPNs detected them. Thorn training is
relatively time-consuming and consequently it will not be
possible to train all of the 6700 CPNs currently in prac-
tice. An alternative model is needed to achieve widespread
changes in practice rapidly and cost-effectively. A brief
manualized medication management training package,
which can be disseminated to entire community mental
health teams, may be a more realistic and effective method
of enhancing practice in this area. Perhaps only when
CPNs receive the training they require will the standards
defined in the National Service Framework (DoH 1999) be
achieved.
References
Bennett J., Done J. & Hunt B. (1995) Assessing the side effects
of antipsychotic drugs: a survey of CPN practice. Journal ofPsychiatric and Mental Health Nursing 2, 177–182.
Brooker C. & White E. (1997) The Fourth QuinquennialNational Community Mental Health Nursing Census ofEngland and Wales. University of Manchester, Manchester.
Casey D. (1996) Extrapyramidal syndromes: epidemiology,
pathophysiology and the diagnostic dilemma. CNS Drugs 5,
1–12.
Day J.C., Wood G., Dewey M. & Bentall R.P. (1995) A self-rating
scale for measuring neuroleptic side-effects: validation in a
group of schizophrenic patients. British Journal of Psychiatry166, 650–653.
DoH (1999). The National Service Framework for Mental Health.Department of Health, London.
Gamble C., Midence K. & Leff J. (1994) The effect of family work
training on mental health nurses’ attitude to and knowledge
of schizophrenia. Journal of Advanced Nursing 19, 893–
896.
Goldberg D. & Gournay K. (1997) The General Practitioner, thePsychiatrist and the Burden of Mental Health Care. Maudsley
Discussion Paper No. 1. Institute of Psychiatry, London.
Gournay K. & Birley J. (1998) Thorn: a new approach to mental
health training. Nursing Times 94, 54–55.
Gray R. (1998) Primary care of schizophrenia: what are the roles
of practice and community psychiatric nurses. CommunityMental Health 1, 5–7.
Guy W. (1976) Assessment Manual for Psychopharmacology.Department of Education and Welfare, Washington DC.
R. Gray et al.
196 © 2001 Blackwell Science Ltd, Journal of Psychiatric and Mental Health Nursing 8, 191–196
Hoge S., Appelbaum P., Lawlor T. et al. (1990) A prospective,
multicentre study of patients’ refusal of antipsychotic medica-
tion. Archives of General Psychiatry 47, 949–956.
Krawiecka M., Goldberg D. & Vaughn M. (1977) A standardised
psychiatric assessment scale for chronic psychiatric patients.
Acta Psychiatrica Scandinavica 55, 299–308.
Lancashire S., Haddock G., Tarrier N. et al. (1997) The impact
of training community psychiatric nurses to use psychosocial
interventions with people who have severe mental health prob-
lems. Psychiatric Services 48, 39–41.
Moore N.A. (1999) Behavioural pharmacology of the new gen-
eration of antipsychotic agents. British Journal of Psychiatry174, 5–11.
van Putten T. (1974) Why do schizophrenic patients refuse to
take their medication. Archives of General Psychiatry 31,
67–72.
Simpson G.M. & Angus J.W.S. (1970) Drug induced extrapyra-
midal disorders. Acta Psychiatrica Scandinivica 45, 11–19.
Wieden P.J., Shaw E. & Mann J. (1987) Causes of neuroleptic
non-compliance. Psychiatric Annals 16, 571–578.